Study of Low Dose Inotuzumab Ozogamicin in Patients With Relapsed and Refractory CD22 Positive Acute Lymphocytic Leukemia

Study Drug Administration:

There are 28 (+/- 7) days in each cycle.

If you are found to be eligible to take part in this study, you will receive the study drug
by vein over about 1 hour on Days 1, 8, and 15 (+/- 3 days) of Cycle 1 and on Day 1 and Day 8
of the remaining cycles.

If your doctor thinks it is needed, you may also receive drugs through a spinal tap
(intrathecally) to help lower the risk of the disease coming back in the fluid surrounding
your brain. You will sign a separate consent for these drugs and this procedure.

You may be given other drugs to help decrease the risk of side effects. Your doctor will tell
you about these drugs, how they will be given, and the possible risks.

Length of Treatment:

You may receive up to 6 cycles of treatment. You will no longer be able to take the study
drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to
follow study directions.

If the disease gets worse after responding for at least 3 months, you may be able to be
retreated for up to 6 additional cycles. If the disease responds to treatment, you may
receive up to 5 additional consolidation cycles of treatment with inotuzumab ozogamicin. You
will continue to have study visits as described above. The study doctor will discuss this
option with you. You are still at risk for side effects due to the study drug. This could
also delay starting other treatments. The disease may also get worse to the point that you
are no longer able to receive other treatments.

Study Visits:

Before each treatment cycle, you will have a physical exam.

One (1) time weekly during Cycles 1-6, blood (about 2-3 tablespoons) will be drawn for
routine tests.

On Days 14 and 21 of Cycle 1, then every 2-3 cycles, you will have a bone marrow biopsy
and/or aspiration.

Inclusion Criteria:

1. Patients at least 12 years of age.

2. Patients with a diagnosis of CD22-positive ALL based on local immunophenotyping and
histopathology) who have: a.Refractory disease, defined as disease progression or no
response while receiving their most recent prior anti-cancer therapy., b.Relapsed
disease, defined as response to their most recent prior anti-cancer therapy with
subsequent relapse.

3. Performance status of 0 to 3.

4. Adequate renal function including serum creatinine or estimated creatinine clearance >/= 15 mL/min as calculated using the method
standard for the institution.

5. Adequate liver function, including total serum bilirubin patient has documented Gilbert syndrome, and aspartate and alanine aminotransferase
(AST or ALT) tumor, total serum bilirubin must be
6. No active or co-existing malignancy requiring chemotherapy or radiation within 6
months.

7. Female subjects of childbearing potential should be willing to use effective methods
birth control or be surgically sterile, or abstain from heterosexual activity for the
course of the study. Subjects of childbearing potential are those who have not been
surgically sterilized or have not been free from menses for > 1 year. Effective
methods of birth control include birth control pills or injections, intrauterine
devices (IUDs), or double-barrier methods (for example, a condom in combination with
spermicide).

8. Male subjects should agree to use an effective method of contraception starting with
the first dose of study therapy through the duration of treatment.

Exclusion Criteria:

1. Pregnant or nursing women

2. Known to be HIV+

3. Ph+ ALL

4. Active and uncontrolled disease/infection as judged by the treating physician

5. Unable or unwilling to sign the consent form

6. Prior allogeneic stem cell transplantation (ASCT) or other anti-CD22 immunotherapy
within
7. Known CNS or extramedullary disease unless approved by the PI.

8. Monoclonal antibodies therapy within 2 weeks before study entry

9. Radiotherapy and cancer chemotherapy (except for intrathecal chemotherapy,
hydroxyurea, and cytarabine. Cytarabine and hydroxyurea are allowed to be used
emergently in case of leukocytosis) or any investigational drug within 2 weeks before
study entry.

10. Evidence or history of veno-occlusive disease (VOD) or sinusoidal obstruction syndrome
(SOS)